FDA-TRACK: Biosimilar User Fee Act Procedural Response Goals Summary

PlantBased Innovations, of Leominster, MA, is recalling Higher Harvest by H-E-B Dairy-Free Coconut Yogurt, Strawberry flavor because the product may contain undeclared almond. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if

C3TI aims to promote the adoption of pragmatic design in clinical trials and improve coordination and collaboration between CDER and sponsors to effectively support these innovative trials.

CINCINNATI, October 4, 2025 – The Kroger Co. (NYSE: KR), said today it has recalled Basil Pesto Bowtie Salad and Smoked Mozzarella Penne Salad that was sold in the Kroger Family of Stores in following states: AK, AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, LA, MI, MO, MS, MT, NE, NM, NV, OH, OR, SC

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/11/2025
Short Title (70 char) Denver Solutions, LLC. Englewood, CO. 483 issued 12/11/2025
FEI Number 3013438582
Firm Name Denver Solutions, LLC
Record Type 483
State CO
Establishment Type Outsourcing Facility

CGMP/Finished Pharmaceuticals/Adulterated

FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria